Osang Healthcare, a South Korean manufacturer and distributor of medical devices, announced that after receiving approval from the FDA on March 18, the cumulative order quantities of COVID-19 test kits had surpassed 10 million. All orders received so far will be shipped later this month.
The company has provided COVID-19 test kits to more than 30 countries, including the United States, Brazil, Russia, Italy, Romania, Morocco, Kuwait, and Argentina. In order to export the test kit, it is required to pass the strict technical requirements offered by the FDA in each country. Among them, the U.S. FDA has the highest entry barrier.
However, on April 18, the company announced that it obtained emergency use authorization (EUA) by the U.S. FDA on its COVID-19 test kit, GeneFinder™ COVID-19 Plus RealAMPKit. Compared to other EUA-approved products, it has been approved as a universal kit that almost all equipment can use. Thus, the company was able to supply test kits across the United States.
"The process of obtaining emergency use authorization, which demands strict technical requirements, had never been easy. I am so proud and happy to be approved by the U.S. FDA for emergency use for the first time in Korea. This is because all employees, such as the dedicated team research center and quality team, worked together in a unified way based on the technology accumulated in the field of diagnostic equipment for 20 years," said Lee Dong-Hyun, CEO of Osang Healthcare.
Meanwhile, unlike the competitors that can detect two genes, Osang Healthcare's test kit can identify all three target genes (E, RdRp, N), making the test results highly accurate. Also, as the reagents are user-friendly and efficient, It is highly regarded as a suitable product for mass inspection.
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